Liaoning Biomedical Materials R&D Center Co., Ltd.

SERY


Safety and Efficacy Registry of Yinyi® stent (SERY)

Organization

Type: Prospective, Clinical Registry
Principal Investigator:
Weifeng Shen, MD, Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Guoying Zhu, MD, Wuhan Asia Heart Hospital
CRO: Beijing Meihua Medical Information Company
Core Lab: Shanghai Jiaotong University, Cardiovascular Institute
Sponsor: Liaoning Biomedical Materials R&D Center Co., Ltd.

Stent

Yinyi® Polymer-free Paclitaxel-Eluting Coronary Stent

Patients

1045 patients

Primary Endpoint

MACE at 12, 24, 36 months
MACE = Death, MI, TLR

Secondary Endpoints

1.Stent thrombosis at 36 months (ARC Definition)
2.Restenosis & Late lumen loss at 9-12 months

Clinical Results

SERY was the first large-scale clinical trial of YINYI polymer-free paclitaxel-eluting coronary stent after it was launched in 2008. As a study focused on polymer-free DES, SERY had a largest enrolled number in the world range at that time. There were 27 sites enrolled 1045 patients, and 1713 YINYI were implanted. The primary and secondary endpoints had been reported successively in GW-ICC during 2010-2012, and the results were exciting.

Polymer-free DES accelerates the endothelialization on the basis of lower restenosis. There is no late catch-up or late stent thrombosis while durable polymer DES has. SERY trial demonstrated YINYI polymer-free PES has DES's efficacy and BMS's safety.